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Talk to Your Doctor

Talk to Your Doctor

DOCTOR DISCUSSION GUIDE FOR 4-WEEK ARM

Visit 1 (Day 1, Week 1)

On your first visit, you can expect to undergo several vision tests and procedures. You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about starting the study?

  • What are your concerns?

Questions to ask the study doctor:

  1. What can I expect to happen over the course of the study?

  2. What should I tell my loved one(s) or caregiver after a visit?

  3. Please describe the study procedure.

  4. Is the procedure pain-free?

  5. How will I know if lampalizumab is working?

  6. Are there any side effects I should watch for?

Visit 2 (Day 8, Week 2)

Today, you will not undergo the study procedure; however, you can expect to undergo several vision tests and procedures, including having blood drawn.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed problems in your study eye?

You should also let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking, or new medications you have been prescribed.

Questions to ask the study doctor:

  1. Do you see any problems in my eye, and how does it compare to the last time?

  2. What does the photographic examination of the inside of my eye show?

  3. Why are you taking samples of my blood?

Visit 3 (Week 4)

Today, you will undergo the study procedure and many of the same vision tests and procedures you had on your first visit.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Do you see any problems in my eye, and how does it compare to last time?

  2. What does the photographic examination of the inside of my eye indicate?

  3. What does the finger-counting test tell you about my vision?

Visits 4–7 (Weeks 8–20)

During these visits, you can expect to undergo several of the same vision tests and procedures you had during your last visit; however, you will not have samples of your blood drawn.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Do you see any problems in my eye, and how does it compare to last time?

  2. What does the photographic examination of the inside of my eye indicate?

  3. What does it mean if the eye pressure changes before or after each treatment?

Visit 8 (Week 24)

Today you can expect to undergo several blood and vision tests and procedures, including a test of your vision in low light.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Do you see any problems in my eye, and how does it compare to last time?

  2. What does the photographic examination of the inside of my eye indicate?

Visits 9–13 (Weeks 28–44)

During these visits, you will undergo many of the same tests and procedures as you did during your last visit; however, you will not have samples of your blood taken.

  • You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Do you see any problems in my eye, and how does it compare to last time?

  2. What does the photographic examination of the inside of my eye indicate?

  3. Has my macular degeneration progressed, and what does this mean?

Visit 14 (Week 48)

Today you can expect to undergo several blood and vision tests and procedures, including a test of your vision in low light and a reading-speed test.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Has my reading speed decreased, and what does this mean?

  2. Why do I have to answer the questionnaires again?

  3. Has my macular degeneration progressed, and what does this mean?

  4. Do you see any problems in my eye?

Visits 15–19 (Weeks 52–68)

During these visits, you will undergo many of the same vision tests and procedures as in previous visits.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Do you see any problems in my eye, and how does it compare to my last visit?

  2. What does the photographic examination of the inside of my eye indicate?

Visit 20 (Week 72)

Today you can expect to undergo several blood and vision tests and procedures, including a test of your vision in low light and a reading-speed test. You’ll also be asked to complete two questionnaires.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Has my reading speed decreased, and what does this mean?

  2. Has my macular degeneration progressed, and what does this mean?

  3. Do you see any problems in my eye?

Visits 21–25 (Weeks 76–92)

During these visits, you can expect to undergo many of the same vision tests and procedures as you have in most of your previous visits.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Do you see any problems in my eye?

  2. What does the photographic examination of the inside of my eye indicate?

Visit 26 (Week 96)

This is your last visit. Today you can expect to undergo all of the blood and vision tests and procedures you’ve had during the study, plus the reading-speed test.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about finishing the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. What happens once I finish the study?

  2. Has my macular degeneration progressed, and what does that mean?

  3. Has the progression of my disease slowed, and what does this mean?

  4. What should my course of action be after this study?

  5. Can I take lampalizumab after the study is over?

DOCTOR DISCUSSION GUIDE FOR 6-WEEK ARM

Visit 1 (Day 1, Week 1)

On your first visit, you can expect to undergo several vision tests and procedures. You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about starting the study?

  • What are your concerns?

Questions to ask the study doctor:

  1. What can I expect to happen over the course of the study?

  2. Please describe the study procedure?

  3. Is the procedure pain-free?

  4. How will I know if lampalizumab is working?

  5. Are there any side effects I should watch for?

Visit 2 (Day 8, Week 2)

Today you can expect to undergo several vision tests and procedures, including having samples of your blood drawn.
You should start by letting the study doctor know how you are feeling, both physically and emotionally.

  • How are you feeling about the study?

  • What are your concerns?

  • Have you noticed any problems in your study eye?

You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

Questions to ask the study doctor:

  1. Do you see any problems in my eye, and how does it compare to the last time?

  2. What does the photographic examination of the inside of my eye show?

  3. Why are you taking samples of my blood?

    Visits 3–5 (Weeks 6–18)

    During these visits, you can expect to undergo many of the same vision tests and procedures you had on your first visit. You may have your heart activity monitored at selected sites (visit 3, week 6 only).
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. Do you see any problems in my eye, and how does it compare to last time?

    2. What does the photographic examination of the inside of my eye show?

    3. Did the eye pressure change before and after my treatment?

    4. Has my macular degeneration progressed, and what does this mean?

    Visit 6 (Week 24)

    Today you can expect to undergo several blood and vision tests and procedures as well as a finger-counting test.
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. Do you see any problems in my eye, and how does it compare to last time?

    2. What does the photographic examination of the inside of my eye show?

    3. Has my macular degeneration progressed, and what does this mean?

    4. What does the finger-counting test measure?

    Visits 7–9 (Weeks 30–42)

    During these visits, you can expect to undergo many of the same vision tests and procedures you had on your last visit; however, you won’t be getting a blood test.
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. Do you see any problems in my eye, and how does it compare to last time?

    2. What does the photographic examination of the inside of my eye show?

    3. Has my macular degeneration progressed, and what does this mean?

    Visit 10 (Week 48)

    Today you can expect to undergo several vision tests and procedures. Plus you will be asked to complete the National Eye Institute Questionnaire and take a reading-speed test.
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. Do you see any problems in my eye, and how does it compare to last time?

    2. Has my reading speed slowed down?

    3. Has my macular degeneration progressed, and what does this mean?

    Visits 11–13 (Weeks 54–66)

    During these visits, you will undergo many of the same tests and procedures as you did during your last visit, except you don’t need to complete another questionnaire or take a reading-speed test.
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. Do you see any problems in my eye, and how does it compare to last time?

    2. What does the photographic examination of the inside of my eye show?

    Visit 14 (Week 72)

    Today you can expect to undergo several blood and vision tests and procedures, including a test of your vision in low light and a reading-speed test. You’ll also be asked to complete two questionnaires.
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. Do you see any problems in my eye, and how does it compare to last time?

    2. Has my macular degeneration progressed, and what does this mean?

    Visits 15–17 (Weeks 78–90)

    Today you can expect to undergo several blood and vision tests and procedures, including a test of your vision in low light and a reading-speed test. You’ll also be asked to complete two questionnaires.
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. Do you see any problems in my eye, and how does it compare to last time?

    2. What does the photographic examination of the inside of my eye indicate?

    3. Did the eye pressure change before and after my treatment?

    Visit 18 (Week 96)

    This is your last visit. Today you can expect to undergo all of the blood and vision tests and procedures you’ve had during the study, plus the reading-speed test.
    You should start by letting the study doctor know how you are feeling, both physically and emotionally.

    • How are you feeling about finishing the study?

    • What are your concerns?

    • Have you noticed any problems in your study eye?

    You should let the study doctor know about any new health problems since your last visit and any changes in the medications you’ve been taking.

    Questions to ask the study doctor:

    1. What happens once I finish the study?

    2. Has my macular degeneration progressed, and what does that mean?

    3. Has the progression of my disease slowed, and what does this mean?

    4. What should my course of action be after this study?

    5. Can I take lampalizumab after the study is over?

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